JP5036992B2 - Catheter with fixation device and stabilization device - Google Patents

Abstract

A catheter is provided having a catheter body whose distal end has an anchoring device and a stabilizing device that are adapted to respectively sit in and sit outside of an opening of a tubular region, such as an ostium of a pulmonary vein. A sheath covering the catheter body forms the anchoring device and the stabilizing device. In particular, the anchoring device and/or the stabilizing device comprises a plurality of slits cut into the sheath where the slits create spines. In one embodiment, the sheath is fixed at its distal end to the distal end of the catheter body. The spines of the anchoring device and the stabilizing device are deployed into radial expansion by distal movement of the sheath relative to the catheter body. Upon radial expansion of the anchoring device, the spines of the anchoring device exert pressure against the walls of the tubular region thereby generally anchoring the distal end of the catheter body inside the tubular region against proximal and/or radial movement relative to the tubular region. Upon radial expansion of the spines of the stabilizing assembly, the spines of the stabilizing device exert pressure against the ostium of the tubular region thereby generally stabilizing the distal end of the catheter body against distal and/or radial movement relative to the tubular region. Accordingly, the pressure exerted on the walls of the tubular region by the anchoring device and on the ostium by the stabilizing device minimizes, if not prevents, the distal end of the catheter body against both translational and rotational movement. In particular, the pressure exerted on the ostium of the tubular region by the stabilizing device stabilizes the catheter within the heart for delivery of ablation energy to treat the desired area of the heart. Other embodiments of the catheter are also contemplated, such as those having a telescoping portion extending distally from the distal end of the catheter. As such, the anchoring and stabilizing devices are deployed by proximal movement of a puller wire whose distal end is affixed to the distal end of the telescoping portion.

Description

Disclosure details

(Field of the Invention)
The present invention is directed to a mapping and / or ablation catheter having a multi-projection fixation device, and more particularly a mapping having a multi-projection fixation device for use in a tubular region in or near the heart. And / or directed to an ablation catheter.

BACKGROUND OF THE INVENTION
Electrode catheters have been widely used in medical practice for many years. Electrode catheters are used to stimulate and map cardiac electrical activity and to cauterize where electrical activity is abnormal. In use, an electrode is inserted into an important blood vessel, i.e. an artery such as the aorta, and guided to the ventricle in question. Often, the area of interest of the heart is a tubular area such as the pulmonary artery, coronary artery, superior vena cava, and inferior vena cava.

  Electrode catheters are used to identify and / or cauterize tissue in areas of the heart that exhibit abnormal electrical activity. In many cases, the electrode catheter can both perform tissue mapping to locate the location of abnormal electrical activity and cauterize the identified tissue. Ablation of such tissue separates the tissue from the rest of the heart, thereby preventing abnormal electrical pathways from spreading to other areas of the heart. One area of the heart where it is usually desirable to perform ablation is the pulmonary artery. Some catheters, such as those described in US Pat. Nos. 6,024,740 and 6,117,101, are designed to cauterize a tubular wound inside the pulmonary artery. These catheters include an ablation element, such as an ultrasonic transducer, which is surrounded by an inflatable balloon. To cauterize the desired tubular wound, the balloon is inflated, the catheter is secured within the pulmonary artery, and the transducer is activated to form a tubular wound in the tissue with which the balloon is engaged.

  Despite being effective in making tubular wounds in heart tissue, these balloon catheters have several drawbacks. For example, balloons are often not placed accurately in the pulmonary artery and / or deviated from a fixed location. In addition, blood cannot flow through the balloon, blood accumulates at the distal end of the balloon, and the blood coagulates. Accordingly, there is a need for a mapping and / or cauterization catheter having a locking mechanism that does not move, allowing blood flow and preventing coagulation.

[Summary of the Invention]
The present invention is directed to a catheter having a catheter body, the distal end of the catheter body having a fixation device and a stabilization device, the fixation device and the stabilization device, respectively, of the mouth of the pulmonary artery. Such an arrangement is placed inside or outside the opening of the tubular region. A sheath covering the catheter body forms a fixation device and a stabilization device. Specifically, the fixing device includes a plurality of slits cut into the sheath, and the slits form protrusions having substantially the same length and width in the sheath. Similarly, the stabilization device includes a plurality of slits cut into the sheath at a location near the fixation device. This slit creates a protrusion in the sheath that is approximately equal in length and width. The protrusion of the stabilization device is longer than the protrusion of the fixing device.

  In certain embodiments, a sheath is secured at its distal end to the distal end of the catheter body. The protrusions of the fixation device and the stabilization device are deployed by moving the sheath distally with respect to the catheter body. This movement of the sheath distally causes the protrusions of the fixation device and the stabilization device to bend outward and the fixation device and the stabilization device to expand radially. The distal end of the catheter body is located in the heart so that the fixation device is in a tubular region such as the pulmonary artery and the stabilization device is adjacent to the mouth outside the same tubular region. Or placed nearby. As the fixation device expands radially, the protrusion of the fixation device exerts pressure on the wall of the tubular region, thereby causing the distal end of the catheter body within the tubular region to be proximal to the tubular region and / or Almost fixed against radial movement. As the stabilizer projections expand radially, the stabilizer projections apply pressure to the mouth of the tubular region, thereby causing the distal end of the catheter body to move distally and / or radially to the tubular region. Try not to move about the direction movement. Thus, the pressure exerted by the anchoring device on the wall of the tubular region and the pressure exerted by the stabilizing device on the mouth is minimized if not preventing both translational and rotational movement of the distal end of the catheter body. To do. In particular, the pressure exerted by the stabilization device on the mouth of the tubular region secures the catheter in the heart to deliver ablation energy to treat the desired region of the heart.

  In an alternative embodiment, the distal end of the catheter body has a slide telescopic portion with a proximal slide telescopic member and a distal slide telescopic member. A sheath covers the proximal and distal slide telescopic members by extending at least from the distal end of the distal slide telescopic member to the proximal end of the proximal slide telescopic member. The distal end of the sheath is attached to the distal end of the distal slide telescopic member, and the proximal end of the sheath is attached to the distal end of the catheter body, proximal to the proximal slide elastic member. It has been. A pull cable is attached to the distal end of the sheath, and the distal end of the sheath is secured to the distal end of the distal slide telescopic member to radially expand the securing device and the stabilizing device. Specifically, the proximal movement of the pull cable retracts the distal and proximal slide telescopic members to radially expand the anchoring and stabilizing device skeleton.

  In either embodiment, the radial extent in both the fixation device and the stabilization device can be adjusted by adjusting the amount of relative translation between the sheet and the catheter body. The ability to adjust the radial extent of the fixation and stabilization devices allows pressures of varying magnitudes to be applied to the wall or mouth of the tubular region. Thus, the anchoring device and the stabilizing device can be closely matched to various shaped tubular regions. Also, to prevent undesired damage to the walls of the tubular region, the stabilization device absorbs any excessive pressure that is inadvertently applied to the fixation device. To that end, for example, a stop in the form of a ring that is fixedly attached to the catheter body or the slide telescopic part limits the amount of radial expansion of the fixation device and / or the stabilization device.

[Detailed explanation]
The present invention is directed to a catheter 10 having an anchoring device and a stabilizing device disposed at or near the distal end of the catheter. As shown in FIG. 1, the catheter has an elongated catheter body 12 having a proximal end 13 and a distal end 15, an operating handle 16 at the proximal end of the catheter body, and a fixation at the distal end of the catheter body 12. Device 17. The catheter may optionally further comprise a stabilization device 19 located near the fixation device 17 at the distal end of the catheter body 12.

  As shown in FIG. 5, the catheter body 12 includes an elongate tubular structure that has only one axial bore, or central lumen 18, but is optional if desired. It can have multiple lumens. The catheter body 12 is flexible, i.e. bendable, but cannot be substantially compressed in its longitudinal direction. The catheter 12 can be of any suitable structure and can be made of any suitable material. The presently preferred structure comprises an outer wall 21 made from polyurethane or PEBAX (polyether block amide). A mesh knitted with stainless steel or the like is embedded in the outer wall 21 to increase the torsional rigidity of the catheter body 12. For this reason, when the operation handle 16 is turned, the distal end of the catheter body 12 turns correspondingly.

  The outer diameter of the catheter body 12 is not critical, but is preferably about 8 French (about 2.67 mm) or less, more preferably about 7 French (about 2.33 mm). Similarly, the thickness of the outer wall 21 is not critical, but is preferably thin enough so that the central lumen 18 can accommodate pull wires, lead wires, sensor cables, and any other wires, cables and tubes. If desired, the inner surface of the outer wall 21 is lined with a reinforcing tube 27 to improve the stability against torsion.

  The fixation device 17 is disposed at the distal end of the catheter body 12. As shown in FIG. 2, the fixation device 17 comprises at least two, preferably at least four spine 20, which extend substantially along the longitudinal axis of the catheter body. , Radial symmetry around the catheter body. In the illustrated embodiment, the fixing device 17 is formed by cutting a slit around a part of the sheath 23. The sheath 23 extends substantially from end to end of the catheter body and covers the catheter body 12 between the proximal end 13 and the distal end 15. In the embodiment of FIG. 2, the distal end of the sheath 23 is fixed to the distal end 15 of the catheter body 12, and the remainder of the sheath 23 proximal to it is slidable relative to the catheter body 12. It has become. The slit of the sheath 23 forms the skeleton 20 of the fixing device 17. The skeleton 20 of the fixation device 17 in the illustrated embodiment is approximately equal in length and width, and is sufficiently long so that when the fixation device 17 is compressed, the skeleton 20 expands sufficiently radially, such as a pulmonary artery. The catheter is secured against proximal and / or rotational movement within the tubular region 25 (FIG. 2a). It will be appreciated by those skilled in the art that, if desired, the skeleton 20 may be formed with different lengths and / or widths so that the fixation device 17 extends radially asymmetrically.

  The stabilizing device 19 in proximity to the fixation device 17 via the non-expanding part of the sheath 27 also comprises at least two, preferably at least four skeletons 22, which skeletons 22 are longitudinal axes of the catheter body. And is radially symmetric about the catheter body 12. The stabilizing device 19 is made substantially the same as the fixing device 17. The slit is cut around a portion of the sheath 23 covering the catheter body 12 on the proximal side of the fixation device 17. These slits form the skeleton 22 of the stabilization device 19. The skeleton portion 22 of the stabilization device 19 in the illustrated embodiment is substantially equal in length and width, but is usually longer than the skeleton portion 20 of the fixation device 17, and the skeleton portion 22 is curved outward so that Is also spreading radially. As shown in FIG. 2a, the skeletal portion 21 curves outward and expands more radially, with the stabilization device 19 snugly attached to the ostium 31 of the pulmonary artery and the distal end of the catheter body distally It is intended to be fixed against movement and / or rotational movement. It will be appreciated by those skilled in the art that, if desired, the slits may be formed with different lengths and / or different widths so that the stabilizing device extends asymmetrically in the radial direction.

  The sheath 23 is made of any material that is flexible, non-conductive and incompressible and is moved distally to move the sheath 23 to the distal end 15 of the catheter body 12. When compressed in the direction, the skeleton part 20 of the fixing device 17 is curved outward as shown in FIG. 2 so as to spread radially to a desired extent. The sheath can be made from a polymer or polymer blend, or any other biocompatible material used in the patient's body. In the illustrated embodiment, the placement of the anchoring device 17 is such that the sheath 12a is advanced distally relative to the catheter body by hand at or near the proximal end of the sheath external to the patient, thereby allowing the patient to This can be done by advancing the remaining portion of the sheath in the body distally, so that the fixation device 17 at the distal end of the sheath is compressed and the skeleton 20 is radially expanded.

  Preferably, the catheter body 12 includes a stop that limits compression of the fixation device. The catheter body may further comprise another stop that limits compression of the stabilization device. The stop may have any shape suitable to limit the sheath 23 from traveling distally. For example, as shown in FIGS. 2 and 2 a, the stop may consist of rings 30 and 32 that are arranged so as not to move to a predetermined position of the catheter body 12. Specifically, a ring 30 is disposed at a location between the distal end 15 of the catheter body and the proximal end of the fixation device 17 and a ring 32 is disposed between the proximal and distal ends of the stabilization device 19. Is arranged. When the proximal end of the fixation device 17 reaches the ring 30, the fixation device cannot be further contracted and is maximal in the radial direction. Similarly, once the proximal end of the stabilization device 19 reaches the ring 32, the stabilization device 19 cannot shrink further and is maximal in the radial direction. Thus, the radial extent of the fixation device 17 and / or the stabilization device 19 is limited according to the position at which the rings 30 and 32 are fixed to the catheter body 12, respectively.

  The longitudinal movement of the sheath 23 is performed, for example, by the user advancing distally by hand or by appropriately operating the operation handle 16. If desired, the operating handle 16 may have a restraining mechanism that causes the sheath 23 to move relative to the catheter body when the securing device 17 and / or the stabilizing device 19 is spread in a desired amount in the radial direction. And fix it on the spot. The stop mechanism of the operating handle operates independently from the stopper of the fixing device 17, i. The restraining mechanism of the operating handle may be of any shape suitable for securing the sheath 23 in place and preventing the sheath 12a from moving further distally and / or proximally. For example, a clamp ring 34 is provided at the proximal end of the sheath such that the clamp ring 34 removably clamps the sheath to the catheter body so that the proximal end of the sheath does not move distally and / or proximally. It may be.

  According to the present invention, advancement of the sheath 23 distally relative to the catheter body 12 compresses the stabilization device 19 and / or the fixation device 17 and usually, but not necessarily, compresses the fixation device 17. It takes place before the compression of the stabilization device 19. In use, the catheter is advanced in its non-invasive configuration (see FIG. 2) through the patient's body until it reaches the ventricle. In the ventricle, the distal end of the catheter body is placed in the tubular region 25, eg, the pulmonary artery, and the sheath 23 is advanced distally to the appropriate level, ie, the proximal end of the fixation device is in the ring 30. Until then, the fixing device 17 is spread radially. Stabilizer 19 is also radially expanded by advancing the sheath distally to an appropriate level, ie, the proximal end of the stabilizer is at ring 32. Thus, as shown in FIG. 2A, by radially expanding the fixation device, the fixation device is secured against rotational movement and / or proximal movement inside the pulmonary artery, while the stabilization device is radially expanded. This forces the stabilization device against the mouth 31 to prevent or at least minimize rotational movement and / or distal movement. With the distal end 15 of the catheter body 12 secured to the tubular region 25 in this manner, the catheter will ablate at any time using the distal electrode 40 and / or ultrasonic ablation means 42, as described in detail below. be able to.

  According to the present invention, when the fixation device 17 spreads to the maximum in the radial direction, the stabilization device 19 absorbs any excessive pressure applied by continuing to advance the sheath 23. Such a structure prevents the fixation device 17 from absorbing excessive pressure, thereby preventing the fixation device 17 from adversely damaging the walls of the tubular region. Alternatively, stops such as rings 30 and 32 may be used to prevent the fixation device 17 and / or the stabilization device 19 from absorbing any excessive pressure. A restraining mechanism, such as a clamp ring 34, can also be used to fix the radial extent of the stabilization device 19 and press it against the mouth of the pulmonary artery.

  When it is necessary to pull the distal end 15 of the catheter body 12 out of the tubular region 25, the clamp ring 34 is removed and the user manually moves the sheath 23 in the proximal direction so that the fixation device 17 and the stabilization device 19 Minimize and minimize radial spread. The distal end 15 that has returned to its non-invasive shape can be easily removed from the tubular region and can be relocated to another tubular region or removed entirely from the patient's body.

  In an alternative embodiment shown in FIG. 3, a sheath 23a covers the distal end 15a of the catheter body 12a, which has a slide telescopic portion 54 having two slide telescopic members 56 and 58. Has been modified. In the illustrated embodiment, the sheath 23a has a reduced length and extends from the distal end 60 of the slide telescopic portion 54 and slightly passes the proximal end 62 of the slide telescopic portion 54. The distal end of the sheath 23 a is fixed to the distal end 60 of the slide telescopic part, and the proximal end of the sheath is fixed to the distal end of the catheter body 15. The securing device 17a formed from the distal portion of the sheath 23a is disposed substantially over the slide telescopic member 54, and the stabilizing device 19a formed from the proximal portion of the sheath is provided on the slide telescopic member 56. Is placed on top. A non-expanding portion 27a of the sheath separates the device 17a and the device 19a. As described above, slits are cut around the sheath 23a to form the skeleton portions 20a and 22a of the fixing device 17a and the stabilizing device 19a. The skeleton portions 20a and 22a may be approximately equal in length and width, or may not be approximately equal. The stabilization device 19a proximate to the fixation device 17a is longer than the fixation device 17a, but short enough so that the place for attaching the ablation device close to the stabilization device 19a is at the distal end of the catheter body 12. . The cautery device is a ring electrode, which will be examined in detail later.

  In order to deploy the anchoring device 17a and / or the stabilizing device 19a in its radially widened shape, an incompressible, usually stiff puller cable 60 is provided in the lumen of the slide telescopic portion and the catheter body 12a. It extends through the lumen 18a and is fixed at its distal end to the distal end of the slide telescopic portion 54. The distal end of the slide stretchable portion 54 is further fixed to the distal end of the sheath 23a. The proximal end of the pull cable 60 is disposed in the operating handle 16 and is connected to a suitable operating mechanism that moves the pull cable 60 proximally and distally. By moving the pull cable 60 proximally, the fixation device 17a and / or the stabilization device 19a is compressed. This compression causes the skeletal portions 20a and 22a to curve outward, thereby spreading the fixation device and the stabilization device radially. The curvature of the skeletons 20a and 22a, and hence the extent of radial expansion of the anchoring device 17a and the stabilizing device 19a, can be adjusted by controlling the proximal distance that the pull cable 60 is pulled. The slide elastic member 56 may have a stopper such as a ring 30a in order to prevent the fixing device 17a from further spreading radially after the radial spread reaches a predetermined level. Similarly, the slide telescopic member 58 may have a stop, such as a ring 32a, to prevent the stabilizing device 19a from spreading further radially after the radial extent has reached a predetermined extent. . The rings 30a and 32a are positioned so as not to move with the respective slide telescopic members 56 and 58 so that the slide telescopic member 58 does not move further proximally when the ring 32a is at the distal end of the catheter body 12. In addition, and / or when the ring 30a is at the distal end of the slide telescopic member 58, the slide telescopic member 56 is not further moved proximally.

  According to the present invention, by moving the pull cable 60 proximally and retracting the distal end of the slide telescopic member 56, the stabilization device 19a and / or the fixation device 17a contract, at this time, but not always, The compression of the stabilization device 19a occurs before the fixing device 17a. In use, the catheter is advanced in its non-invasive shape (see FIG. 3) through the patient's body until the catheter reaches the ventricle. In the ventricle, the distal end of the slide telescopic member 56 is placed in the tubular region 25, eg, the pulmonary artery, and the pull cable 60 is pulled proximally by appropriately manipulating the operating handle 16, thereby further sliding the telescopic member. Pull 56 and 58 proximally. As shown in FIG. 3A, the stabilization device 19a is radially expanded until the appropriate level, i.e., the ring 32a is at the distal end 15 of the catheter body 12, and the fixation device 17a is The ring 30a is radially expanded until it is at the proximal end of the slide telescopic member 58. Thus, the radial expansion of the fixation device 17a fixes the fixation device against a rotational movement and / or proximal movement inside the tubular region, for example the pulmonary artery, while the stabilization device 19a expands radially. In this way, the stabilization device is pressed against the mouth 31 of the tubular region, preventing or at least minimizing rotational movement and / or distal movement. With the distal end of the catheter body secured in this manner, the catheter can be cauterized at any time using the distal electrode 40a and / or the ultrasonic ablation member 42a, as will be described in detail later.

  When the fixing device 17a spreads out to the maximum in the radial direction, the stabilizing device 19a absorbs all excessive pressure applied by continuing to advance the sheath 23a. Such a structure does not allow the fixing device 17a to absorb any excessive pressure, and thus does not cause the fixing device 17a to do any inconvenient damage to the walls of the tubular region. Alternatively, stops such as rings 30 and 32a may be used to prevent the fixing device 17a and / or the stabilization device 19a from absorbing any excessive pressure. The mechanism for manipulating the pull cable 60 also secures the cable in place to prevent the devices 17a and 19a from moving distally and / or proximally after being placed at or near the mouth of the pulmonary artery. Can be remodeled.

  Thus, the pull cable 60 attached to the distal end of the sheath 23a controls the radial spread of both the fixation device 17a and the stabilization device 19a. Proximal movement of the pull cable 60 compresses both the fixation device 17a and the stabilization device 19a. By compressing in this way, the skeleton parts 20a and 22a are curved outward, whereby the fixing device 17a and the stabilizing device 19 are spread radially. The degree of curvature of the skeletons 20 and 20a, and hence the radial extent of the anchoring device 17 and the stabilizing device 19, can be adjusted by controlling the proximal distance from which the pull cable 60 is pulled.

  When it is necessary to pull the slide telescopic part 54 out of the tubular region 25, the operating handle 16 is operated to advance the pull wire 60 so that the radial spread of the fixing device 17 and the stabilizing device 19 is reduced and minimized. When the pull cable 60 is sufficiently stiff and / or properly supported by its own sheath to advance the catheter body within the patient's body, the pull cable may become a sliding telescopic member. 54 can be supported and maintained in a shape extending distally from the distal end of the catheter body, and the slide telescopic members 56 and 58 can be properly extended to return the distal end to its non-invasive shape. This is natural for those skilled in the art. The catheter body 12 that has returned to its non-invasive shape can be easily removed from the tubular region and repositioned to another tubular region or removed entirely from the patient's body.

  If there is a desire to change the compression amount of the fixing device and / or the stabilizing device, or if it is appropriate to do so, the slide expansion / contraction part 54 may be composed of only one slide expansion / contraction member, Or it is natural for those skilled in the art that it may comprise three or more slide elastic members. Further, if there is a desire to limit the amount of compression of the stabilization device, or where it is appropriate to do so, the ring 30 may be placed near the portion 27a of the slide telescopic portion 54, It is natural for those skilled in the art. Even with a plurality of slide expansion / contraction members, the maximum extension of the slide expansion / contraction portion to the distal end depends on the length of the pulling cable 60 and / or the corresponding expansion / contraction end of the adjacent slide expansion / contraction member. It is limited by providing an edge, i.e. a flange, that prevents the member from coming off.

  In any of the above embodiments, the radial extent of the fixation device and the stabilization device can be adjusted. The ability to adjust the radial extent of the fixation device allows different amounts of pressure to be applied to the tubular region, for example the wall of the pulmonary artery. For example, the physician manipulates the catheter to expand the device until sufficient pressure is applied to the wall of the tubular region to secure the catheter to the region, and then activates a restraining mechanism to install the device. Can be fixed in the position. Once fixed, no greater or lesser pressure is applied to the tubular region and / or mouth wall. The ability to fix the radial extent of the fixation device allows the device to be adapted to many different shapes within any tubular region or mouth. This ability is therefore extremely beneficial. This is because the shape and contour of the tubular region and mouth vary within the heart and vary with each patient. In addition, the ability to control the pressure on the tubular region and the mouth wall allows the catheter to be secured against both translational and / or rotational movements so that it does not wobble. Since the stabilization device is placed in close proximity to the fixation device, the stabilization device can absorb any excessive pressure that may be inadvertently applied to the fixation device. Such a construction prevents improper fixing devices, i.e. any excessive damage to the wall of the tubular region.

  As shown in FIG. 8, the catheter body 12c is composed only of the fixing device 17c, and the fixing device 17c is formed of the sheath 23c, and the distal end of the sheath 23c is fixed to the distal end 15c of the catheter body. It may be done. The maximum radial extent of the device 17c is set by a ring 30c, which is immovably disposed on the catheter body 12c. Furthermore, as shown in FIG. 9, the catheter body 12d may be composed of only the fixing device 17d. The fixing device 17d is formed of a sheath 23d, and the distal end of the sheath 23d is a slide telescopic member 56d. It is fixed to the distal end. The slide telescopic member 56d is moved distally and proximally by the pull cable 60. The maximum radial extent of the device 17d is set by a ring 30d, which is immovably arranged on the member 56d. In any of these embodiments, an ultrasonic transducer and a protective balloon can be attached to the proximal side of the fixation device if desired.

  One or more ring electrodes can optionally be attached to the sheath of any catheter embodiment. In particular, as shown in FIGS. 2, 2a, 3 and 3a, the ring electrode 28 is preferably mounted on the sheath, distal to the fixation device and proximal to the stabilization device. The ring electrode 28 can be used for mapping systems and / or cauterization. Thus, each of the ring electrodes 28 is connected to an appropriate mapping or monitoring system and / or ablation energy source using electrode lead wires 29 as shown in FIGS. Each electrode lead wire 29 extends through the operating handle 16 or 16a, passes through a hole in the catheter bodies 12 and 12a, and is connected to a corresponding electrode 28 (only one electrode 28 is shown in FIGS. 4 and 5). Have been). Each lead wire 29 is covered with a non-conductive skin and attached to the corresponding lead electrode 28 by any suitable means.

  A preferred method of attaching the lead wire 29 to the ring electrode 28 involves first drilling small holes in the walls of the sheaths 23 and 23a. Such a hole can be made, for example, by inserting a needle through the sheath and heating the needle sufficiently to form a permanent hole. Next, the lead wire 29 is pulled through the hole using a micro hook or the like. Next, all the coating is peeled off from the end portion of the lead wire 29, welded to the lower side of the ring electrode 28, and then slid into an appropriate position through the hole, and appropriately fixed with polyurethane adhesive or the like. Alternatively, each ring electrode 28 is formed by winding the lead wire 29 around the sheaths 23 and 23 a several times, and peeling off the insulation coating of the lead wire 29 itself on the surface facing the outside of the lead wire 29 from the lead wire 29. Form.

  In the catheter 12 of FIGS. 2, 2a and 4, each lead wire 29 is considerably longer than the length between the ring electrode and the connection of the lead wire to the operating handle. This extra length of the lead wire 29 causes the lead wire 29 to move distally with the sheath 23 to radially expand the skeleton 20 of the fixation device 17 and / or the skeleton 22 of the stabilization device 19. Can do. When the sheath is moved in this manner, the lead wire 29 passes between the sheath 23 and the catheter body 12. As will be appreciated by those skilled in the art, the extra length of the lead wire 29 can be accommodated in the operating handle with a mechanism that allows the extra length to be provided as required.

  Alternatively, as shown in FIGS. 2, 2A, 3 and 3A, the catheter body may include a peripheral ablation device such as an ultrasonic transducer 65 mounted in the stabilization devices 19 and 19a. In this arrangement, the stabilization device is covered with an inflatable balloon 67. The inflatable balloon 67 is secured at the distal and proximal ends to the sheaths 23 and 23a to seal the ultrasonic transducer 65 from blood and other fluids in the heart and tubular regions. Examples of such ultrasonic transducers and balloon mechanisms that can be used in the present invention are disclosed in US Pat. No. 6,780,183, the disclosure of which is hereby incorporated by reference. . Since the ultrasonic transducer 65 cannot transmit ablation energy through the stabilizer skeleton, a suitable embodiment of the stabilizer preferably includes at least two skeletons, but no more than three. Never exceed. In such a configuration, the ultrasonic transducer 65 can transmit the ablation energy to the location of interest, while still allowing the catheter to be secured, for example, around the mouth of the pulmonary artery.

  In an alternative embodiment, as shown in FIGS. 6, 6A, 7 and 7A, an ultrasonic transducer 65 is attached to sheaths 23 and 23a proximal to stabilizers 19 and 19a and is inflatable. Covered with a simple balloon 67. Balloon 67 is fixedly attached to the sheath at its proximal and distal ends. In this embodiment, the stabilizing devices 19 and 19a are preferably provided with at least two protrusions, but no more than three so that the transducer 31 can transmit the ablation energy around the stabilizing device 19. I have to.

  In any of the above embodiments, the catheter optionally further comprises means for deflecting the distal ends of the catheter bodies 12 and 12a. The deflection means comprises a puller wire 40, which is fixed at its distal end to the distal end of the catheter body as shown in FIGS. The puller wire 40 is made of any suitable material, such as stainless steel or Nitinol, and is preferably coated with Teflon or the like. This coating provides smoothness to the puller wire 40. The puller wire preferably has a diameter in the range of 0.006 inches to 0.010 inches (0.152 mm to 0.254 mm).

  A compression coil 42 is disposed within the catheter body so as to surround the puller wire 40. The compression coil extends from the proximal end of the catheter to the distal end of the catheter. The compression coil 42 is made of any suitable metal, and is preferably made of stainless steel. The compression coil 42 is tightly wound on itself and is flexible, that is, can be bent, but is difficult to compress. The inner diameter of the compression coil 42 is preferably slightly larger than the diameter of the puller wire 40. For example, if the puller wire 42 has a diameter of about 0.007 inch (0.178 mm), the compression coil 42 preferably has an inner diameter of about 0.008 inch (0.203 mm). The Teflon coating on the puller wire 40 allows the puller wire 40 to slide freely within the compression coil 42. Along the longitudinal direction of the compression coil 42, the outer surface of the compression coil is covered with a flexible and non-conductive sheath so that the compression coil 42 and the lead wire 29 are in contact within the catheter body 12. Is preventing. A non-conductive sheath 44 made of polyimide is currently preferred.

  The compression coil 42 is secured at its proximal end to the proximal end of the stiffening tube of the catheter body 12 by an adhesive joint 50 and is adhesively joined at its distal end to the distal end of the catheter body 12. It is fixed by the part 51. Both of the adhesive joints 50 and 51 are preferably made of a polyurethane adhesive or the like. The adhesive can be applied through a hole created between the outer surface of the catheter body 12 and the single lumen 18 using a syringe or the like. Such a hole can be formed, for example, with a needle or the like, which pierces the wall of the catheter body 12 and the reinforcing tube 22, and is heated sufficiently to create a permanent hole. The adhesive is then passed through the hole to the outer surface of the compression coil 42 and is sucked around the outer surface to form an adhesive joint around the entire circumference of the compression coil 42.

  The puller wire 40 extends through the hole in the catheter body 12 and into the distal end of the catheter body 12. The distal end of puller wire 40 is secured within the distal end of catheter body 12. The puller wire 40 extends from end to end through a sheath 45 made of plastic, preferably made of Teflon. The sheath 45 prevents the puller wire 40 from cutting into the wall of the catheter body 12 when the distal end of the catheter body 12 is deflected. The puller wire 40 is deflected by moving the puller wire 40 longitudinally relative to the catheter body 12.

  An electromagnetic sensor 72 can be placed in the distal end of the catheter body 12. The electromagnetic sensor 72 may extend from the distal end of the catheter body 12 to the distal end of the fixation device 12. Alternatively, the electromagnetic sensor 72 may be partially extended into the fixing device 17. The electromagnetic sensor 72 is attached to the distal end of the catheter body 12 by any suitable means, such as a polyurethane adhesive.

  The electromagnetic sensor 72 is connected to an electromagnetic sensor cable 74. The electromagnetic cable 74 extends from end to end in the hole in the catheter body 12 and exits through the operating handle 16. The electromagnetic sensor cable 74 consists of a plurality of wires encased in a sheath covered with plastic. In the operation handle 16, a sensor cable 74 is connected to a circuit board (not shown). The circuit board amplifies the signal input from the electromagnetic sensor 72 and sends it to the computer in a form that the computer can understand. Since the catheter is designed for single use, an EPROM may be placed on the circuit board, which shuts down the circuit board about 24 hours after the catheter is used. This prevents the catheter, or at least the electromagnetic sensor from being used twice.

  Electromagnetic sensors suitable for use in the present invention are described, for example, in U.S. Patent Nos. 5,580,901, 5,434,489, 5,480,422, 5,541,951, and 5,391,199, the disclosures of which are incorporated herein by reference. Are hereby incorporated by reference. A preferred electromagnetic sensor 72 has a length of about 6 mm to about 7 mm and a diameter of about 1.3 mm.

  Suitable handle mechanisms for manipulating the pull cable 60 and / or pull cable 40 are in US Pat. Nos. 6210407, 6171277 and 6198974, the disclosure of which is incorporated herein by reference. It shall be introduced into the specification.

  The foregoing description has been made in connection with a presently preferred embodiment of the invention. Those skilled in the art to which the present invention pertains will appreciate that modifications and variations of the described structure may be made without departing from the principle, spirit and scope of the present invention without meaningful departure. Therefore, the foregoing description should not be construed as referring only to the structure described and shown in the accompanying drawings, but rather is closely tied to the claims and It should be understood as support. The claims must give their maximum and fairest scope.

Embodiment
(1) A catheter that can be used in or within a tubular region of the heart,
An elongated catheter body having a proximal end and a distal end;
A fixation device configured to restrict rotation and proximal movement of the distal end of the catheter body relative to the tubular region when the fixation device is radially expanded;
A stabilization device proximal to the fixation device, which limits rotation and distal movement of the distal end of the catheter body relative to the tubular region when the stabilization device is radially expanded. A stabilizing device adapted to:
The fixation device and the stabilization device are formed from a slit cut in a sheath, the sheath being disposed at least at the distal end of the catheter body and remote from the catheter body. A catheter adapted to move proximally and proximally to radially expand the fixation device and the stabilization device.
(2) The catheter according to embodiment 1,
The catheter, wherein the fixation device is arranged in the tubular region and is configured to press a peripheral wall portion of the tubular region when radially expanded.
(3) The catheter according to embodiment 1,
The catheter, wherein the stabilizing device is arranged at or near the mouth of the tubular region and presses the mouth when radially expanded.
(4) The catheter according to embodiment 1,
The securing device is adapted to be disposed in the tubular region and, when radially expanded, presses against a peripheral wall of the tubular region, and further comprises the stabilization A catheter, wherein the device is arranged at or near the mouth of the tubular region and is adapted to press the mouth when radially expanded.
(5) The catheter according to embodiment 1,
A portion adjacent to the portion of the sheath where the slit is formed in a direction orthogonal to the longitudinal direction of the catheter body is a skeleton portion, and the skeleton portion extends in the longitudinal direction of the catheter body. There is a catheter.

(6) The catheter according to embodiment 5,
Each skeletal part of the fixation device is a catheter having an equal length.
(7) The catheter according to embodiment 5,
Each skeletal portion of the stabilization device has an equal length.
(8) The catheter according to embodiment 5,
The catheter, wherein the skeleton of the fixation device is different in length from the skeleton of the stabilization device.
(9) The catheter according to embodiment 1,
A catheter that moves the sheath distally to radially expand at least one of the fixation device and the stabilization device.
(10) The catheter according to embodiment 1,
A catheter that moves the sheath proximally to radially spread at least one of the fixation device and the stabilization device.

(11) The catheter according to embodiment 1,
A catheter, wherein the fixation device is fixed to the distal end of the catheter body, and the sheath is moved distally to spread at least one of the fixation device and the stabilization device radially.
(12) The catheter according to embodiment 1,
At least one of the fixation device and the stabilization device is disposed in a slide telescopic portion distal to the distal end of the catheter body, and the slide elastic portion is moved proximally to move the fixation device and the A catheter that radially spreads at least one of the stabilizing devices.
(13) The catheter according to embodiment 1,
A catheter further comprising means for ablating tissue at or near the tubular region.
(14) The catheter according to embodiment 1,
Means for deflecting the distal end of the catheter body, the means including a puller wire having a proximal end and a distal end, wherein the proximal end of the puller wire does not move into an operating handle The distal end of the puller wire is fixedly attached to the distal end of the catheter body, and the longitudinal movement of the puller wire causes the distal end of the catheter to A catheter that deflects its distal end.
(15) The catheter according to embodiment 1,
The catheter further comprising an electromagnetic sensor attached to the distal end of the catheter body.

(16) The catheter according to embodiment 1,
A catheter further comprising at least one ring electrode, the ring electrode being attached to the non-conductive sheath distal to the fixation device.
(17) The catheter according to embodiment 1,
A catheter further comprising at least one ring electrode, the ring electrode being attached to the sheath proximate to the fixation device.
(18) The catheter according to embodiment 1,
A catheter further comprising at least one ring electrode, the ring electrode being attached to the non-conductive sheath distal to the fixation device.
(19) The catheter according to embodiment 1,
A catheter further comprising at least one ring electrode, the ring electrode being attached to the sheath proximal to the stabilization device.
(20) The catheter according to embodiment 1,
A catheter further comprising a peripheral ablation device mounted in the stabilization device.

(21) The catheter according to embodiment 20,
The peripheral ablation device is an ultrasonic transducer, and the stabilization device is covered with an inflatable balloon.
(22) The catheter according to embodiment 1,
A catheter further comprising a stop to limit radial spread of at least one of the fixation device and the stabilization device.
(23) The catheter according to embodiment 1,
A catheter further comprising an ablation device attached to the sheath proximal to the stabilization device.
(24) The catheter according to embodiment 23,
The ablation device is an ultrasound transducer placed in an inflatable balloon.
(25) The catheter according to embodiment 1,
The catheter has at least four skeleton parts.

(26) The catheter according to embodiment 4,
The catheter, wherein the stabilization device has at least four skeletons.
(27) a catheter,
An elongate catheter body having a proximal end and a distal end and having at least one lumen extending from end to end of the catheter body;
A non-conductive sheath attached to the catheter body so as to surround the non-conductive sheath, and is slidable relative to the catheter body;
A fixation device comprising a plurality of skeleton parts, wherein the skeleton part is formed by cutting a longitudinal slit around the periphery of the distal end of the non-conductive sheath;
A stabilizing device comprising a plurality of skeletons, the skeletons cutting longitudinal slits around the distal end of the non-conductive sheath at a position proximal to the fixation device A stabilization device formed of
An operating handle attached to the proximal end of the catheter body,
A catheter in which the skeletal portion of the fixation device and the skeletal portion of the stabilization device expand radially by distal movement of the non-conductive sheath relative to the catheter body.
(28) a catheter,
An elongate catheter body having a proximal end and a distal end and having at least one lumen extending from end to end of the catheter body;
A non-conductive sheath attached to the catheter body so as to surround the non-conductive sheath and attached to the catheter body so as not to move except for a distal end of the non-conductive sheath;
A fixation device comprising a plurality of skeleton parts, wherein the skeleton part is formed by cutting a longitudinal slit around the periphery of the distal end of the non-conductive sheath;
A pull cable having a proximal end and a distal end, wherein the pull cable is attached such that the distal end of the pull cable does not move to the distal end of the non-conductive sheath;
An operating handle attached to the proximal end of the catheter body,
A catheter in which the skeletal portion of the fixation device radially expands due to longitudinal movement of the pull cable relative to the catheter body.
(29) The catheter according to embodiment 28,
A catheter wherein each skeleton has an equal length.
(30) The catheter according to embodiment 28,
A catheter where each skeleton has an equal width.

(31) The catheter according to embodiment 28,
And further comprising a stabilizing device comprising a plurality of skeletons, the skeletons being longitudinally around the periphery of the distal end of the non-conductive sheath and at a location on the sheath proximal to the fixation device. A catheter in which the skeletal portion of the stabilizing device is radially expanded by the longitudinal movement of the pulling cable relative to the catheter body.
(32) The catheter according to embodiment 31,
The catheter wherein the skeletal portion of the stabilization device is longer than the skeleton portion of the fixation device.
(33) The catheter according to embodiment 31,
A catheter wherein the skeletal portion of the stabilization device has the same length.
(34) The catheter according to embodiment 31,
A catheter wherein the skeletal portions of the stabilization device have the same width.
(35) The catheter according to embodiment 28,
Means for deflecting said distal end of said catheter body, said means for deflecting comprising a puller wire, said puller wire having a proximal end and a distal end, said proximal end of said puller wire being The puller wire is fixedly mounted in the operating handle and the distal end of the puller wire is fixedly mounted on the distal end of the catheter body, and the puller wire is moved longitudinally. The catheter deflects the distal end of the catheter.

(36) The catheter according to embodiment 28,
The catheter further comprising an electromagnetic sensor mounted in the distal end of the catheter body.
(37) a catheter,
An elongate catheter body having a proximal end and a distal end and having at least one lumen extending from end to end of the catheter body;
A non-conductive sheath attached to the catheter body so as to surround the non-conductive sheath and attached to the catheter body so as not to move except for a distal end of the non-conductive sheath;
A fixation device comprising a plurality of skeleton parts, wherein the skeleton part is formed by cutting a longitudinal slit around the periphery of the distal end of the non-conductive sheath;
A stabilizing device comprising a plurality of skeletons, the skeletons cutting a longitudinal slit around the periphery of the distal end of the non-conductive sheath at a position close to the fixation device A stabilizing device formed;
A pull cable having a proximal end and a distal end, wherein the pull cable is attached such that the distal end of the pull cable does not move to the distal end of the non-conductive sheath;
An operating handle attached to the proximal end of the catheter body,
A catheter in which the skeletal portion of the fixation device radially expands due to longitudinal movement of the pull cable relative to the catheter body.

These and other features and advantages of the present invention will become better understood when considered in conjunction with the accompanying drawings, with reference to the following detailed description.
FIG. 1 is a perspective view of an embodiment of a catheter according to the present invention. FIG. 2 is an enlarged perspective view of the distal end of the catheter body according to one embodiment of the present invention. FIG. 2A is an enlarged perspective view of the catheter of FIG. 2 when placed in a tubular region of the patient's heart. FIG. 3 is an enlarged perspective view of the distal end of a catheter body according to another embodiment of the present invention. FIG. 3A is an enlarged perspective view of the catheter of FIG. 3 when placed in a tubular region of the patient's heart. 4 is a longitudinal sectional view of a part of the catheter body in FIGS. 2 and 2A. FIG. 5 is a longitudinal sectional view of a part of the catheter body in FIGS. 3 and 3A. FIG. 6 is an enlarged perspective view of the distal end of a catheter body according to another embodiment of the present invention. 6A is an enlarged perspective view of the catheter of FIG. 6 when placed in a tubular region of the patient's heart. FIG. 7 is an enlarged perspective view of the distal end of a catheter body according to another embodiment of the present invention. FIG. 7A is an enlarged perspective view of the catheter of FIG. 7 when placed in a tubular region of the patient's heart. FIG. 8 is a perspective view of another embodiment of the catheter of the present invention without a stabilizing device. FIG. 9 is a perspective view of yet another embodiment of the catheter of the present invention without a stabilizing device.

Claims (23)

A catheter usable in or within a tubular region of the heart,
An elongated catheter body having a proximal end and a distal end;
A slide telescopic portion located distal to the distal end of the catheter body and including a proximal slide telescopic member and a distal slide telescopic member;
A fixation device configured to restrict rotation and proximal movement of the distal end of the catheter body relative to the tubular region when the fixation device is radially expanded;
A stabilization device proximal to the fixation device, which limits rotation and distal movement of the distal end of the catheter body relative to the tubular region when the stabilization device is radially expanded. A stabilizing device adapted to:
The fixation device and the stabilization device are formed from a slit cut into a sheath, the sheath being between the distal end of the catheter body and the distal end of the distal slide telescopic member. A catheter disposed and adapted to radially expand the fixation device and the stabilization device by moving the slide telescopic portion proximally relative to the catheter body. The catheter according to claim 1,
The catheter wherein the fixation device is disposed on the distal slide telescopic member and the stabilization device is disposed on the proximal slide telescopic member. The catheter according to claim 1,
A pull cable extending inside the catheter body and the slide telescopic portion, the distal end of the pull cable being fixed to the distal end of the distal slide telescopic member, A catheter adapted to radially expand the fixation device and the stabilization device by moving to a position. The catheter according to claim 1,
The catheter further comprising at least one stop that limits radial spread of at least one of the fixation device and the stabilization device. The catheter according to claim 1,
A first stop that limits the radial spread of the fixation device, and a second stop that limits the radial spread of the stabilization device;
The first stopper is fixed to the distal slide expansion / contraction member and stops the proximal slide movement of the distal slide expansion / contraction member when contacting the distal end of the proximal slide expansion / contraction member. ,
The catheter, wherein the second stopper is fixed to the proximal slide expansion / contraction member and stops the proximal slide expansion / contraction member from moving proximally when contacting the distal end of the catheter body. The catheter according to claim 1,
The securing device is adapted to be disposed in the tubular region and, when radially expanded, presses against a peripheral wall of the tubular region, and further comprises the stabilization A catheter, wherein the device is arranged at or near the mouth of the tubular region and is adapted to press the mouth when radially expanded. The catheter according to claim 1,
A portion adjacent to the portion of the sheath where the slit is formed in a direction orthogonal to the longitudinal direction of the catheter body is a skeleton portion, and the skeleton portion extends in the longitudinal direction of the catheter body. There is a catheter. The catheter according to claim 7,
Each skeletal part of the fixation device is a catheter having an equal length. The catheter according to claim 7,
Each skeletal portion of the stabilization device has an equal length. The catheter according to claim 7,
The catheter, wherein the skeleton of the fixation device is different in length from the skeleton of the stabilization device. The catheter according to claim 1,
A catheter further comprising means for ablating tissue at or near the tubular region. The catheter according to claim 1,
Means for deflecting the distal end of the catheter body, the means including a puller wire having a proximal end and a distal end, wherein the proximal end of the puller wire does not move into an operating handle The distal end of the puller wire is fixedly attached to the distal end of the catheter body, and the longitudinal movement of the puller wire causes the distal end of the catheter to A catheter that deflects its distal end. The catheter according to claim 1,
The catheter further comprising an electromagnetic sensor attached to the distal end of the catheter body. The catheter according to claim 1,
A catheter further comprising at least one ring electrode, the ring electrode being attached to the non-conductive sheath distal to the fixation device. The catheter according to claim 1,
A catheter further comprising at least one ring electrode, the ring electrode being attached to the sheath proximal to the fixation device. The catheter according to claim 1,
A catheter further comprising at least one ring electrode, the ring electrode being attached to the non-conductive sheath distal to the fixation device. The catheter according to claim 1,
A catheter further comprising at least one ring electrode, the ring electrode being attached to the sheath proximal to the stabilization device. The catheter according to claim 1,
A catheter further comprising a peripheral ablation device mounted in the stabilization device. The catheter according to claim 18, comprising:
The peripheral ablation device is an ultrasonic transducer, and the stabilization device is covered with an inflatable balloon.
A catheter further comprising. The catheter according to claim 1,
A catheter further comprising an ablation device attached to the sheath proximal to the stabilization device. A catheter according to claim 20,
The ablation device is an ultrasound transducer placed in an inflatable balloon. The catheter according to claim 1,
The catheter has at least four skeleton parts. A catheter according to claim 6,
The catheter, wherein the stabilization device has at least four skeletons.

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